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  4. Webinar - Draft Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle - 10/15/2024
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Webcast | Virtual

Event Title
Webinar - Draft Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle
October 15, 2024

Date:
October 15, 2024
Time:
1:00 p.m. - 2:00 p.m. ET

Summary

On October 15, 2024, the FDA held a webinar for interested parties to answer questions about this draft guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.

Background

When finalized, the guidance Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle is intended to provide recommendations on how patient preferences can be collected and shared with the FDA and be considered in decision-making. The guidance will also outline the types of patient preference studies that can provide reliable scientific evidence.

The FDA encourages medical device companies to use patient preference information to inform the entire product lifecycle. This includes considering what patients want to achieve with a treatment, what they're willing to tolerate in terms of risks, and what they value most. Patient preference information (PPI) can be applied throughout the entire product lifecycle, from early development to post-market evaluation.

Additionally, the FDA may include patient preferences information in its decision summaries for medical devices. This information can be used to:

  • inform FDA decision-making at various stages, helping to ensure that devices are safe and effective for patients.
  • help ensure patients are informed about the benefits and risks of a device and can make more informed decisions about their care.

Webinar Materials

The presentation, printable slides, and transcript are available on this webpage and at CDRH Learn under "How to Study and Market Your Device", sub-section "Cross-Cutting Premarket Policy."

If you have questions about this draft guidance document, please contact the CDRH Patient Preference Inbox at CDRH-PPI@fda.hhs.gov. If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

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